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Phenylephrine Pregnancy and Breastfeeding Warnings

Brand names: AH-Chew D, Biorphen, Congest Aid II, Contac-D, Despec-SF, Dimetapp Toddler's Drops Decongestant, Gilchew IR, Help I Have A Stuffy Nose, Little Colds Decongestant, Lusonal, Nasal Decongestant PE, Nasop, Nasop12, Neo-Synephrine, PediaCare Children's Decongestant, Phenyl-T, Ricobid-D, Sudafed PE Children's Nasal Decongestant, Sudafed PE Congestion, Sudogest PE, Suphedrine PE, Triaminic Thin Strips Cold with Stuffy Nose, Vazculep

Medically reviewed by Drugs.com. Last updated on Sep 29, 2023.

Phenylephrine Pregnancy Warnings

Animal studies have not been conducted. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.


US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is not recommended unless clearly needed.

AU TGA pregnancy category: B2
US FDA pregnancy category: C

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.

See references

Phenylephrine Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-Animal data indicate this drug may decrease milk production.

See references

See also

References for pregnancy information

  1. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee. Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. http://www.tga.gov.au/docs/html/medpreg.htm 2010.
  2. Product Information. Phenylephrine Hydrochloride (phenylephrine). Cipla USA Inc. 2019.

References for breastfeeding information

  1. United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.
  2. Product Information. Phenylephrine Hydrochloride (phenylephrine). Cipla USA Inc. 2019.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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